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FDA 510(k)

iTOF®

K-Number: K242525 · 2024-12-05

ApplicantNerbio Medical Software Platforms, Inc.
Decision Date2024-12-05
Product CodeKOI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

iTOF® is the device name listed in this FDA 510(k) record. The listed applicant is Nerbio Medical Software Platforms, Inc.. It received FDA 510(k) clearance on 2024-12-05 under 510(k) number K242525. The device is classified under product code KOI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iTOF®?

iTOF® is a medical device that received FDA 510(k) clearance on 2024-12-05. The listed applicant is Nerbio Medical Software Platforms, Inc.. The 510(k) number is K242525.

When did iTOF® receive FDA 510(k) clearance?

iTOF® received FDA 510(k) clearance on 2024-12-05, under 510(k) number K242525.

Who is the listed applicant for iTOF®?

The FDA 510(k) record lists Nerbio Medical Software Platforms, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iTOF®?

The FDA product code for iTOF® is KOI.

Related Devices (Code: KOI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)Senzime ABK250887Neuromuscular Transmission Monitor TOF3D (2510091)MIPM Mammendorfer Institut für Physik und Medizin GmbHK243339WiTOFIdmedK220530Tetragraph Neuromuscular Transmission MonitorSenzime ABK220976Life Scope PT BSM-1700 Series Bedside MonitorNihon Kohden CorporationK212434Neuromuscular Transmission Monitor TOF3DMIPM Mammendorfer Institut für Physik und Medizin GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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